Surgical instrument access device

ABSTRACT

A surgical access device includes a valve that forms a seal with a body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal for an instrument. The valve can include a gel material and the access channel can include a protective shield to provide for wound protection during insertion and withdrawal of a sharp surgical instrument. The valve further comprises a cap ring which may be inserted or molded with the gel material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/564,409, filed on Nov. 29, 2006, which is a continuation of U.S.patent application Ser. No. 10/666,579, filed on Sep. 17, 2003, thedisclosures of which are hereby incorporated by reference as if setforth in full herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to devices and other apparatusfacilitating sealed access with surgical instruments across a body walland into a body cavity.

2. Discussion of the Prior Art

In several areas of surgery there exists a need to have mechanisms ordevices that can seal a body cavity or space, and yet permit theintroduction of surgical instruments of different sizes such asguidewires, endoscopes and staplers. Typical of these areas of surgeryis laparoscopic surgery which relies on surgical instruments insertedthrough the abdominal wall to reach an operative site within theabdominal cavity. In order to increase space around the operative sitewithin the cavity, insufflation gases are typically introduced toinflate the cavity and elevate the abdominal wall. This pressurizing ofthe abdominal cavity is referred to as pneumoperitoneum. In thiscontext, the need to seal the body cavity or space arises from the needto maintain the pneumoperitoneum even when the instruments are present.

Trocars have been commonly used to provide instrument access inlaparoscopic surgeries. These trocars have included elaborate sealstructures having zero seals which prevent escape of the gases in theabsence of instruments, and instrument seals which prevent escape of thegases in the presence of instruments. Unfortunately, the instrumentseals have been able to accommodate only a narrow range of instrumentdiameters. Where wider ranges were desired multiple seal pairs had to beprovided.

Some instruments such as surgical staplers and those having diameters upto about 37 mm have been too large for trocar access. Furthermore,present trocar seals typically require two valves, one for forming aninstrument seal in the presence of the instrument, and the other forforming a zero seal in the absence of the instrument. Accordingly, thereis a need in the art for a surgical access device that can function bothas a zero seal and as an instrument seal, and that can accommodate awide range of instruments having diameters up to about 37 mm.

SUMMARY OF THE INVENTION

The deficiencies of the prior art are overcome with the presentinvention which includes a seal apparatus. In one embodiment, the deviceincludes a valve structure formed of a gel including, for example, athermoplastic base such as KRATON® and an oil. The resulting elastomerhas excellent tear strength, high elongation, a very low durometer orhardness, and biocompatibility. The access device can function both as azero seal and as an instrument seal. Furthermore, it can accommodate afull range of instruments having diameters up to about 37 mm. In anotherembodiment, several instruments of smaller diameter can be accommodatedat the same time with a single access device.

Both tear resistance and sealing capability can be enhanced byencapsulating the gel in a sheath or otherwise providing circumferentialreinforcement for the valve structure. Additives can be provided eitheron or in the gel to enhance properties such as lubricity, appearance,wound treatment and/or protection, anti-cancer protection andanti-microbial protection. Additional chemicals, compounds,pharmaceuticals or even mechanical devices can be mixed with or embeddedin the gel material to vary chemical, pharmaceutical or physicalproperties of the access device.

These and other features and advantages of the invention will beclarified with a description of preferred embodiments and reference tothe associated drawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view showing a patient prone on an operatingtable with his abdomen insufflated, and with instrument access providedby trocars and the access device of the present invention;

FIG. 2 is an enlarged side elevation view of the access deviceoperatively disposed exteriorly of the abdominal wall;

FIG. 3 is a plan view taken along lines 5-5 of FIG. 2;

FIG. 4 is a perspective exploded view of a further embodiment includinga gel cap, a base and a wound retractor;

FIG. 5 is a top plan view of a gel cap of an access device of theinvention;

FIG. 6 is a cross-section view of an access device of the inventionincluding a gel cap, a base, a wound retractor, and a protective sleeveformed around an inner diameter of a cap ring of the gel cap;

FIG. 7 is a three-dimensional view of the protective sleeve formedaround the inner diameter of the cap ring of the access device of theinvention;

FIG. 8 is a three-dimensional view of a protective sleeve formed aroundan inner diameter of a cap ring of an access device in accordance toanother embodiment of the invention;

FIG. 9 is a cross-section view of an access device in accordance withanother embodiment of the invention including a gel cap, a base, a woundretractor, and a protective sleeve formed around an inner diameter of acap ring of the gel cap;

FIG. 10 is a cross-section view of an access device in accordance withanother embodiment of the invention including a gel cap, a base, a woundretractor (not shown), and a protective sleeve formed around an innerdiameter of a cap ring of the gel cap;

FIG. 11 illustrates a cross-section view and a three-dimensional view ofthe wound retractor of an access device of the invention including aninner ring, an outer ring, and a flexible sleeve;

FIG. 12 is a top plan view showing use of a template; and

FIG. 13 is an axial cross-section view showing placement of the innerring and securement of the flexible sleeve of the wound retractor of theinvention.

DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

A patient is illustrated in FIG. 1 and designated generally by thereference numeral 10. The patient 10 is shown in a prone position on anoperating table 15, where the operative procedure is performed within anabdominal cavity 20 with instrument access provided through an abdominalwall 25. In this type of operation, commonly referred to as laparoscopicsurgery, trocars 30 and 35 are commonly used to provide minimallyinvasive access through the abdominal wall 25 for instruments such as agrasper 40 and an endoscope 45.

Although the specific focus of this disclosure will be on a preferredlaparoscopic procedure, it will be noted that laparoscopic surgery ismerely representative of a type of operation wherein a procedure can beperformed in a body cavity with minimal access through a body wall.

Notwithstanding the foregoing generality, it is important to note thatwith respect to laparoscopic surgery, it is often desirable thatinstruments having diameters up to 37 mm be able to insert through theabdominal wall 25 and into the abdominal cavity 20 using the same accessdevice. This insertion of the instruments provides a surgeon with directaccess to various elements of the anatomy without having to changeaccess device or use of multiple access devices.

In order to accommodate a wide range of instruments, a small incision 50is typically created in the abdominal wall 25. An access device 55 ofthe present invention can be provided to further facilitate insertion ofwide instruments such as those having diameters up to about 37 mm.

Particularly in the case of laparoscopic surgery, it is advantageous toinsufflate the abdominal cavity 20 with a gas, such as carbon dioxide,in order to elevate the abdominal wall 25 and thereby increase thevolume of the working space within the cavity 20. Maintenance of thisinsufflation pressure, commonly referred to as pneumoperitoneum, isparticularly difficult where access is desired across the abdominal wall25, for example, through the trocars 30, 35, as well as the accessdevice 55. For this reason, a substantial effort has been directed toproviding such access devices with sealing characteristics both in thepresence of instruments and in the absence of instruments, such as thegrasper 40 and scope 45.

Were it not for the desire to maintain the pneumoperitoneum, there wouldbe no need for the trocars 30, 35 or the access device 55. One wouldmerely cut an incision in the abdominal wall 25 and insert theinstrument directly through the incision. However, without appropriatevalves or seals, the insufflation gases would merely escape through theincisions. This would be particularly detrimental in the case of theincision 50 which must be sufficiently large to accept the wide range ofinstruments having diameters up to 37 mm. Thus, it is a primary purposeof the access device 55 to form with the incision 50 an access orworking channel 60, and to provide a valve or other sealing structureacross the working channel 60 in order to maintain the pneumoperitoneum.

An enlarged view of one embodiment of the access device 55 isillustrated in FIG. 2, which also shows the abdominal wall 25 and theincision 50. In this simple form, the access device 55 has the generalconfiguration of a pad 65, meaning that it is generally flat anddisposed in a plane such as the plane 70. Typically parallel to thisplane 70 are a pair of major surfaces of 72 and 74 which provide the pad65 with a substantial surface area. An opening or slit 75 can be formedthrough the pad 65, generally along an axis 80 perpendicular to theplane 70.

When operatively disposed, the opening 75 of the pad 65 is incommunication with the incision 50 and, in this case, forms with theincision 50 and the working channel 60. The alignment of the opening 75and incision 50 can occur with the pad 65 disposed exteriorly of theabdominal wall as illustrated in FIG. 2. The operative disposition ofthe pad 65 relative to the abdominal wall 25 requires that the pad 65 bemaintained in its operative position and that it form a seal around theincision 50. Referring to the plan view of FIG. 3, these two functionsare accomplished with an adhesive 85 disposed around the incision 50between the pad 65 and the abdominal wall 25.

If this adhesive 85 is formed as a continuous ring 90, as illustrated inFIG. 3, the pad 65 can be disposed with the ring 90 positionedcircumferentially around the incision 50 to form a seal between the pad65 and the abdominal wall 25. In the illustrated example, when the pad65 is operatively positioned, the escape of insufflation gases isinhibited between the pad 65 and the abdominal wall 25 by the adhesivering 90.

The escape of insufflation gases is inhibited through the opening 75 ofthe pad 65 by the self-sealing characteristics of the material formingthe pad 65. This material of the pad 65 and its highly advantageousproperties are discussed below.

It will be appreciated that the functions of the adhesive ring 90 can beaccomplished in many different ways using many different materials andshapes. For example, many materials other than adhesives can be used tomaintain the pad 65 in position over the incision 50. The formation of aseal around the incision 50 can also be accomplished with methods otherthan adhesion. Furthermore, the shape of the continuous seal formed bythe adhesive 85 need not be in the shape of a circle. Rather, anycontinuous pattern sufficiently large to form a perimeter around theincision 50 could facilitate the desired sealing relationship.

It will be noted that whenever an instrument is inserted through the pad65, the material of the pad conforms to the surface of the instrumentand forms the instrument seal with the instrument. Accordingly, duringthe entire period beginning with insertion of the instrument and endingwith withdrawal of the instrument, there is substantially no loss ofinsufflation gas through the pad 65 or any loss of pneumoperitoneumwithin the abdominal cavity 20.

It will be appreciated an instrument having a diameter up to 37 mm maybe inserted through the access device 55 of the invention. In theabsence of the instrument, the opening or slit 75 merely closes againstitself to form a zero seal, thus preventing the escape of insufflationgases through the access device 55. When the instrument is insertedthrough the opening or slit 75, an instrument seal is formed between thematerial of the access device 55 and the exterior surface of theinstrument. This prevents the escape of insufflation gases through theaccess device 55, even when an instrument is present. Thus, insufflationpressures can be maintained within the abdominal cavity 20 whether ornot the instrument is in place. Note that these seals, the zero seal andthe abdominal seal, can be formed as a single valve structure havingproperties for accommodating a full range of instrument sizes up to 37mm in diameter.

In most cases, the single access opening 75 is used to accommodate asingle instrument. It is appreciated, however, that the access device 55can also accommodate multiple instruments of smaller diameters. That is,additional openings may be established by merely inserting the desiredoperative instrument through the pad 65. In this manner, the instrumentcan create its own access hole beside the primary opening 75.Particularly for those operative instruments having pointed distal ends,the instrument can merely be forced through the pad 65 forming its ownaccess hole, such as the opening 75, as it is moved distally. Thisopening, created by the operative instrument itself, would automaticallyform an instrument seal as the instrument is inserted, as well as a zeroseal as the instrument is withdrawn.

For operative instruments not having pointed distal ends, it is possibleto form a new access hole using a secondary instrument, such as a trocarobturator. After the access hole is formed, the obturator can beremoved, vacating the access hole to receive the operative instrument.Throughout this process of initially forming an access hole andultimately inserting an operative instrument through the hole, both zeroseals and instrument seals are formed to maintain the pneumoperitoneum.

With the advantages associated with (1) the formation of an instrumentseal and a zero seal with a single valve accommodating a wide range ofdiameters, and (2) the formation of an instrument opening using theinstrument itself, it will be appreciated that the concept of thisinvention will typically be embodied with a structure that isparticularly dependent upon the material which forms the access device55. In a preferred embodiment, the pad 65 is formed of a KRATON®/oilmixture including a KRATON® Tri-block with aStyrene-Ethylene-Butylene-Styrene (S-E-B-S) structure in combinationwith a mineral oil.

As described in co-pending U.S. application Ser. No. 10/381,220, filedon Mar. 20, 2003, entitled “Surgical Access Apparatus and Method,” whichis fully incorporated herein by reference, it can be appreciated that analmost infinite number of combinations, alloys, and Styrene to rubberratios can be formulated, each capable of providing advantages to aparticular embodiment of the invention. These advantages will typicallyinclude low durometer, high elongation, and good tear strength.

A further embodiment of the invention is illustrated in FIG. 4 whereelements of structure similar to those previously disclosed aredesignated with the same reference numeral followed by the lower caseletter “a.” This exploded view of the access device 55 a includes notonly the pad 65 a but also a complimentary structure for maintaining theposition of the pad 65 a, for forming a seal between the pad 65 a andthe abdominal wall 25, and for dilating the incision 50 to a variableextent as required by a surgeon. In this case, the access device 55 aincludes three components, a jell cap 100, base 105, and a woundretractor 110 as described in co-pending International Application No.PCT/US03/17389, filed on Jun. 3, 2003, entitled “Wound Retractor,” whichis fully incorporated herein by reference.

Referring to FIG. 6, there is shown a cross-sectional view of the accessdevice 55 a, with the gel cap 100 and the base 105 attached together andthe wound retractor 110 held therein. The gel cap 100 further includes acircumferential cap ring 102, which can be inserted and molded to thepad 65 a, and a protective shield or sleeve 125, which can be bonded ormolded into cap 100. The shield or sleeve 125 is positioned under pad 65a and circumferentially around an inner diameter of cap ring 102, and isdirected into the incision 50. The shield or sleeve 125 operates toprotect the sheath of wound retractor 110 from sharp instruments as theinstruments are inserted and withdrawn through the pad 65 a; the shield125 also operates to direct instruments through the pad 65 a. The shield125 may be a single tubular member or it may comprise a plurality ofaxially extending sleeve members having a plurality of axial slits asillustrated in FIGS. 7 and 8. The shield 125 may comprise of the same ordifferent materials as the cap ring 102. The resulting gel cap 100 formsa seal with the base 105, thereby defining a working channel 60 athrough the pad 65 a, the cap ring 102, the base 105, and the woundretractor 110. In the manner previously discussed, this working channel60 a includes the single valve formed by the gel pad 65 a which providesboth a zero seal and an instrument seal for a wide range of instrumentdiameters.

The structure associated with the gel cap 100 is described in greaterdetail with reference to FIG. 5. In the top plan view of FIG. 5, it canbe seen that this embodiment includes the gel pad 65 a centrallydisposed within the circumferential cap ring 102. Holding tabs 115 canbe provided to extend radially outwardly of the cap ring 102. Theseholding tabs 115 can facilitate the sealing engagement of the gel cap100 with the base 105 in the manner described in greater detail below.

The gel pad 65 a can be formed of any of the materials previouslydiscussed although the preferred embodiment includes the KRATON©/mineraloil gel. The cap ring 102 for such an embodiment can be advantageouslyformed of KRATON® only. This will make the cap ring 102 more rigid thanthe gel pad 65 a while maintaining an excellent material interfacebetween the pad 65 a and the ring 102. In a typical manufacturingoperation, the cap ring 102 will be pre-disposed in the mold for the gelpad 65 a with the unitary structure of the gel cap 100 resulting.

The cross-section view of FIG. 6 further illustrates an annular void 120formed on the inner circumference of the cap ring 102. This void 120 isof particular advantage in forming a sealing relationship with the base105 in the manner discussed in greater detail below. FIGS. 9 and 10illustrate additional exemplary embodiments of the invention havingmodifications that could be made to the gel cap 100 and/or the base 105so that the access device 55 can be used with the wound retractor 110.Referring back to FIG. 6, it will be noted that the base 105 can beprovided with a generally straight inner surface 130 which extendsdistally to a rounded end surface 135 and outwardly from the end surface135 along an annular lip 145, which is sized and configured to fit intothe annular void 120 formed on the inner circumference of cap ring 102.

In another embodiment of the invention, FIG. 9 illustrates a base 105 bhaving a generally straight inner surface 130 b which extends distallyto a raised wall 140 b and outwardly from the raised wall 140 b along anannular lip 145 b, which is sized and configured to fit into an annularvoid 120 b formed on the inner circumference of a corresponding cap ring120 b. In yet another embodiment of the invention, FIG. 10 illustrates abase 105 c having a raised wall 130 c along an inner diameter and agenerally straight surface 140 c extending distally along an annular lip145 c, which is sized and configured to fit into an annular void 120 cformed on the inner circumference of a corresponding cap ring 120 c.

Referring to FIG. 11, there is shown the incrementally adjustable woundretractor 110 of the invention which operates to seal edges of asurgical incision and forms an opening in a patient's body cavity. Thewound retractor 110 comprises an inner ring 155, an outer ring 160, anda flexible sleeve 165 connecting the inner ring 155 and the outer ring160. The wound retractor 110 provides a path for a surgeon to insertinstruments through the opening formed by the wound retractor 110. Thewound retractor 110 is incrementally adjustable to fit a wide range ofincision sizes. The wound retractor 110 is installed or placed in a bodycavity such that the inner and outer rings 155, 160 expand around innerand outer edges of the incision. Any portion of the flexible sleeve 165extending outside the incision can be easily rolled onto the outer ring160 to tightly seal the sides of the wound. The outer ring 160 ispreferably shaped to provide audible and/or tactile feedback to theuser. The outer ring 160 includes surfaces that are easy to grip andturn to allow the user to manually turn the outer ring 160 and roll upthe flexible sleeve 165 with ease. The outer ring 160 may be solid orinclude a single or multiple lumen(s) with rod(s) placed therein toprovide audible signal to the user as the outer ring 160 is turned.

The method of using the access device of the present invention isillustrated in the progressive use of FIGS. 12 and 13. In FIG. 12, a topplan view of the abdominal wall 25 of the patient 10 is illustrated witha template 200 positioned to facilitate location of the incision 50. Thesize of the incision 50 can be determined with the indicia 205 on thetemplate 200 showing the lengths of the incision. After the incision 50has been cut along the line 210, the template 200 can be removed. Asillustrated in FIG. 13, the wound retractor 110 can then be mountedthrough the incision 50. Initially the inner ring 155 is compressed andfed through the incision 50. On the inner surface of the abdominal wall25, the inner ring 155 is free to expand to its larger diameter. Anyportion of the flexible sleeve 165 extending outside the incision 50 canbe easily rolled onto the outer ring 160 to tightly seal the sides ofthe wound. As noted, when the sleeve 165 is axially stretched, it willcreate radial forces on the abdominal wall 25 which will tend to enlargethe incision 50. The greater the axial stretch, the larger the incision50.

A final step remaining in this process is the attachment of the gel cap100 to the base 105. This is accomplished as illustrated in FIGS. 6, 9and 10 by capturing the annular lip 145 of the base 105 in the annularvoid 120 of the gel cap 100. Bending the holding tabs 115 upwardly andoutwardly facilitates this engagement which ultimately forms a sealbetween the base 105 and the gel cap 100.

Although this invention has been disclosed with reference to certainstructural configurations, it will be appreciated that these productsare merely representative of many different embodiments of theinvention. Accordingly, one is cautioned not to limit the concept onlyto the disclosed embodiments, but rather encouraged to determine thescope of the invention only with reference to the following claims.

1. A surgical access device facilitating a sealing relationship with asurgical instrument extending through the device and into patient, thesurgical access device comprising: a retractor having a proximal end anda distal end with a flexible sleeve extending between the proximal endand the distal end and defining an access channel extending into apatient; a valve structure arranged to be coupled to the retractor andsealing the proximal end of the retractor and the access channel intothe patient; and a protective shield having a nonadjustable length andthe flexible sleeve of the retractor having an adjustable length.
 2. Thedevice of claim 1 wherein the protective shield is coupled to the valvestructure.
 3. The device of claim 1 wherein the protective shield ispositioned between the valve structure and the retractor.
 4. The deviceof claim 1 wherein the valve structure comprises a gel material.
 5. Thedevice of claim 4 wherein the valve structure comprises a cap ringsurrounding the gel material.
 6. The device of claim 1 wherein theprotective shield is a plurality of axially extending shield memberswith an axial slit separating each of the plurality of axially extendingshield members.
 7. The device of claim 1 wherein the protective shieldprovides for wound protection during insertion and withdrawal of theinstrument.
 8. The device of claim 1 wherein the protective shield is asingle tubular member.
 9. A surgical access device facilitating asealing relationship with a surgical instrument extending through thedevice and into patient, the surgical access device, comprising: a capring surrounding a seal forming a zero seal in the absence of theinstrument extending through the seal and forming a seal with theinstrument in the presence of the instrument extending through the seal;and a protective shield positioned circumferentially around an innerdiameter of the cap ring and extendable into the patient, the protectiveshield having a proximal end with a decreasing taper to a middle portionof the protective shield and having a distal end with an increasingtapered from and away from the middle portion of the protective shieldand the protective shield having a fixed nonadjustable length.
 10. Thedevice of claim 9 wherein the inner diameter of the cap ring is largerthan a diameter of the distal end of the protective shield.
 11. Thedevice of claim 9 wherein the protective shield comprises a plurality ofaxially extending shield members.
 12. The device of claim 9 wherein theprotective shield provides for wound protection during insertion andwithdrawal of the instrument.
 13. The device of claim 9 wherein theprotective shield is a single tubular member.
 14. The device of claim 9wherein the protective shield is coupled to the cap ring.
 15. The deviceof claim 9 further comprising a retractor having a proximal end and adistal end with a flexible sleeve extending between the proximal end andthe distal end.
 16. The device of claim 15 wherein the retractor isarranged to be coupled to the cap ring.
 17. The device of claim 15wherein the protective shield is positioned adjacent to the retractor.18. The device of claim 15 wherein the seal is made of gel materialsealing the proximal end of the retractor.